Events

Safety Alert for Trade name: Ureterorenofibroscope. Technical Name: Ureterorenofibroscope. ANVISA registration number: 80124630193. Class of risk: II. Model affected: URF-P6 / P6R. Affected serial numbers: 2613119, 2613237,2613239, 2612933, 2612936, 2612947, 261H189,2613101, 2612937, 2613240, 2613102, 2613844, 2613861, 2613846, 2613847, 2613848, 2613845, 2613864, 2613866, 2612931, 2613077, 2613843.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Olympus Optical do Brasil Ltda; Olympus Medical Systems Corp..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2545
  • Date
    2018-04-17
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    1. Inspect your inventory and identify any URF-P6 / P6R models. 2. Olympus Optical do Brasil Ltda will contact your facility to make arrangements to return your URF-P6 / P6R uretero-rene fibroscope (s), as well as for the subsequent device exchange. You will receive instructions on how to return the URF-P6 / P6R for this exchange. 3. If you are a business partner and have distributed the URF-P6 / P6R, please identify your customers, notify them immediately of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 4. Please indicate in the attached questionnaire that you received this notification. Additionally, please fill in the affected URF-P6 / P6R number in your inventory. E-mail the complete form to [calidad.brasil@olympus.com]. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Olympus received 7 customer complaints about urf-v2 / v2r endoscopes associated with tissue trauma (3 cases), ureter perforation (1 case), and insertion tubes that were stuck inside the patient and had to be surgically removed ( 3 cases). research has shown that breaking within the underlying metal bending tube of the endoscope contributes to adverse events. olympus has modified the curvature mechanism. in an effort to mitigate the occurrence of adverse events, olympus initiated this action by fsca to replace existing products with those with the new curvature mechanism. in addition, for urf-p6 / p6r endoscopes, there were no adverse events associated with curvature section breaking. however, urf-p6 / p6r has a similar but not identical design to urf-v2 / v2r. therefore, in an effort to mitigate the occurrence of adverse events, omsc decided to undertake the same action for urf-p6 / p6r as urf-v2 / v2r.
  • Action
    Field Action Code FA_150_02 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Collection and exchange of impacted unit.

Device

Trade name: Ureterorenofibroscope. Technical Name: Ureterorenofibroscope. ANVISA registration num...

Manufacturer

Olympus Optical do Brasil Ltda; Olympus Medical Systems Corp.